ResMed CPAP masks subject to Class I recall over magnetic interference issue

Six reported injuries related to magnets on the headgear of CPAP machines by ResMed Ltd. have resulted in a recall the FDA labels as class I, the most serious kind, according to an an FDA alert.
The company is recalling all the CPAP masks it makes containing magnets due to concerns that magnetic interference could disrupt medical devices, causing serious injury or death, according to the alert. The recall covers model numbers AirFit N10, AirFit F20, AirTouch F20, AirFit N20, AirTouch N20, AirFit F30 and AirFit F30i.
The magnets are located on the masks’ lower headgear straps and frame

Leave a Comment

Your email address will not be published. Required fields are marked *

Shopping Cart